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Short Hills, N.J. -- The Food and Drug Administration (FDA) granted conditional approval to AB Science for a new treatment for canine mast cell tumors.

Masitinib, marketed as KINAVET-CA1, will be made available to U.S. veterinarians for the treatment of recurrent or nonresectable Grade II and Grade II cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids, the company reports.

Masitinib was previously approved by the European Medicine Agency (EMA) and commercialized in Europe for the treatment of canine mast cell tumors, under the name MASIVET.

Alain Moussy, chairman and CEO of AB Science, says in a prepared statement, “This decision opens the U.S. (veterinary) market for masitinib, which is expected to be our largest market. It is therefore a significant milestone... We will continue to collaborate closely with the FDA to pursue the development of masitinib in the United States, both in veterinary and in human medicine."

Dr. Albert Ahn, president of AB Science USA, adds, “As we continue to generate further data, we are confident that we can establish masitinib as the reference treatment for canine mast cell tumors."

KINAVET-CA1 has been designated a new animal drug by FDA under the Minor Use/Minor Species (MUMS) Act. This entitles KINAVET-CA1 to seven years of exclusive marketing rights beginning on the date of conditional approval.

"The conditional approval is a response to an application that demonstrated reasonable expectations of effectiveness. During the five-year period of conditional approval, AB Science will continue to gather additional data to further support the safety and efficacy of masitinib in designated indications," the company reports.

Mast cell tumors (MCT), also known as a mastocytoma, is the most common cutaneous malignant neoplasm in dogs, accounting for 16 percent to 21 percent of all skin tumors.

The behavior and progression of MCTs are highly heterogeneous. They range from slow-growing tumors with a low potential for metastasis (grade I) to undifferentiated, aggressive tumors (grade II and III) with a high potential for metastasising to local lymph nodes, the liver, spleen and bone marrow, AB Science adds.
Masitinib is an orally administered tyrosine kinase inhibitor that targets mast cells, important cells for immunity, as well as a limited number of kinases that play key roles in various cancers.